510(k) · Cleared
ClearedOrthopedic Fixation Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tinavi (Anhui) Medical Technologies Co., Ltd. · JDW Pin, Fixation, Threaded
Cleared on Apr 14, 2020 as substantially equivalent to K153204 (In2bones Sas, 2016) after a 286-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 14, 2020
- Review
- 286 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960385 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK153204 In2Bones Kirschner wireIn2bones Sas · 2016
- This deviceK191803 Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K153204 | In2Bones Kirschner wire | In2bones Sas | 2016 | — |
| 0 (this device) | K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153204 | In2Bones Kirschner wireSummary page 4…e fixation fastener Classification Panel: Orthopedic Regulatory Class: II Product Code: JDW III. PREDICATE DEVICE Primary predicate device: In2Bones® Kirschner wire (K153204) IV. DEVICE DESCRIPTION The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The de… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K153204.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191803: Orthopedic Fixation Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026